The purpose of this study is to evaluate the safety and clinical characteristics of a quantity of human rhinovirus Type 16 (HRV-16) in healthy volunteers. This source of HRV-16 will be subsequently used in viral challenge studies with new compounds that are intended to treat respiratory diseases.

Each volunteer will receive a single administration of 100 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.

Experimental: HRV-16 (1000 TCID50)

Biological: HRV-16 (1000 TCID50)

Each volunteer will receive a single administration of 1000 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.

Detailed Description:

This is an open-label study in which all participants know the investigational substance being tested. Participants will be inoculated in the nose with HRV-16 and evaluated for the occurrence of cold symptoms and other indicators. There will be 3 phases: a screening phase, an HRV-16 infection phase, and a follow-up phase. The dose of virus being tested in this study has been previously used in other challenge studies. The total length of participation in the study will be about 4 weeks. Participant safety will be monitored.

Eligibility

Ages Eligible for Study:

18 Years to 60 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Demonstrate an understanding of the study and sign an informed consent form prior to any study-related procedures

Healthy with no clinically significant abnormalities as determined by medical history

Women of child-bearing potential and all men must agree to use adequate birth control measures (as determined by the investigator) and must agree to continue to use such measures and not plan a pregnancy until after the Day 6 visit

Men must agree not to donate sperm during the study through the Day 6 visit

Exclusion Criteria:

Have a documented serum-neutralizing antibody titer of > 2-fold dilution to HRV-16 in the blood sample within approximately 40 days of Screening Visit 2

Live with a family member who cares for the elderly, infants, or small children (eg, nursing home or day care provider), or live with someone who has a chronic lung disease, premature infant, or immunocompromised individual

Require a prescription or over-the-counter medication on a regular basis (3 or more times per week), except contraceptive preparations, hormone replacement therapy, or topical acne medication

Have a history of chronic disease that the Investigator believes are clinically significant

Have a history of chronic headaches (eg frequent migraines, cluster headaches) with 3 or more headaches per week

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466738

Locations

United States, Virginia

Charlottesville, Virginia, United States

Sponsors and Collaborators

Centocor Ortho Biotech Services, L.L.C.

Investigators

Study Director:

Centocor Ortho Biotech Services, L.L.C. Clinical Trial

Centocor Ortho Biotech Services, L.L.C.

More Information

Responsible Party:

Sr. Director, Translational Medicine, Janssen Research and Development, US